FDA 510(k)

LC Bead LUMI

K-Number: K162373 · 2016-12-16

Decision Date2016-12-16

Product CodeKRD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

LC Bead LUMI is the device name listed in this FDA 510(k) record. The listed applicant is Biocompatibles UK Limited. It received FDA 510(k) clearance on 2016-12-16 under 510(k) number K162373. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LC Bead LUMI?

LC Bead LUMI is a medical device that received FDA 510(k) clearance on 2016-12-16. The listed applicant is Biocompatibles UK Limited. The 510(k) number is K162373.

When did LC Bead LUMI receive FDA 510(k) clearance?

LC Bead LUMI received FDA 510(k) clearance on 2016-12-16, under 510(k) number K162373.

Who is the listed applicant for LC Bead LUMI?

The FDA 510(k) record lists Biocompatibles UK Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LC Bead LUMI?

The FDA product code for LC Bead LUMI is KRD.

Other records listing Biocompatibles UK Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K150876Bead Block

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.